Sjogren's Lung Study (NCT04843345) | Clinical Trial Compass
SuspendedNot Applicable
Sjogren's Lung Study
Stopped: Indefinite paused for staffing issues
United States500 participantsStarted 2021-04-01
Plain-language summary
Lung involvement in Sjögren's syndrome is common and causes reduced quality of life and increased mortality. Sjögren's syndrome-related lung diseases (SS-RLD) are classified and treated as the primary lung diseases they resemble. Whether this approach is optimal has not been evaluated thoroughly. A critical gap in knowledge is knowing whether SS-RLDs have a unique clinical course and response to therapy. Given the underlying immune system dysfunction in Sjögren's syndrome, the investigators hypothesize that patients with SS-RLD will be more likely to respond to immunosuppressive therapy than patients with the matching primary lung disease. To address this hypothesis, the investigators will prospectively screen for Sjogren's syndrome in patients presenting to pulmonary clinics and compare the clinical course and response to therapy in Sjogren's syndrome positive and negative patients.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Group 1: Interstitial Lung Disease and Other Parenchymal Lung Diseases
* Known or suspected interstitial lung disease regardless of radiographic pattern
* Interstitial lung disease due to alternative autoimmune etiology
* Sarcoidosis
* Organizing pneumonia
* Hypersensitivity pneumonitis absent known or suspected trigger
* Primary pulmonary lymphoma
* Other idiopathic pulmonary conditions at discretion of study team
Group 2: Refractory Airway Symptoms
* Chronic cough despite treatment trials with albuterol, proton-pump inhibitors and anti-histamine and intranasal corticosteroids
* Persistent bronchial hyperreactivity (defined as positive response to methacholine challenge on spirometry or subjective worsening after exposure to airway irritants such as tobacco, pollution, etc) or persistent asthma symptoms despite trial of inhaled corticosteroid and long acting bronchodilator
* Unexplained persistent bronchial wall thickening on CT imaging
* Recurrent or chronic bronchiolitis (including but not limited to chronic bronchiolitis, obliterative bronchiolitis, lymphocytic bronchiolitis, constrictive bronchiolitis associated with bronchiolar destruction, and panbronchiolitis)
* Bronchiectasis
* Lymphocytic alveolitis on bronchoalveolar lavage absent hypersensitivity pneumonitis with known trigger or HIV
* Recurrent bacterial pneumonia (greater than 2 episodes in 1 year, confirmed by focal consolidative opacity on chest imaging and requiring antibiotic therapy)…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in pulmonary function over time
Timeframe: Change from first test after enrollment to final test across 5-year monitoring period